Complete Remission Rate， CRRSCENT-3NCT07542912
Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma
A study testing SCA Induction followed by Response-Adapted Therapy in people with Complete Remission Rate， CRR and Progression Free Survival, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is an open-label, single-arm, multi-center Phase II clinical trial evaluating the efficacy and safety of a novel sequential regimen as first-line therapy for treatment-naïve patients with Extranodal NK/T-cell Lymphoma (ENKTL). The study consists of a Screening Phase, a Safety Lead-in Phase, and a Treatment Phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complete Remission Rate， CRR, Progression Free Survival, Overall Survival
- What is being tested?
- SCA Induction followed by Response-Adapted Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to participate in the clinical study.
- Age ≥ 18 years at the time of signing the Informed Consent Form (ICF).
- Newly diagnosed ENKTL confirmed by histopathology at the study center.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- At least one evaluable or measurable lesion
- Ann Arbor stage I-II disease.
- PINK-E score ≥ 1.
- Adequate organ and bone marrow function, with no severe hematopoietic dysfunction or abnormalities in cardiac, pulmonary, hepatic, renal, or thyroid function, and no immunodeficiency.
Who cannot join
- Aggressive natural killer cell leukemia.
- Presence of hemophagocytic syndrome.
- Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
- Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
- Patients with active chronic hepatitis B or active hepatitis C.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Multicenter, Phase II Study of Sintilimab Combined With Chidamide and Azacitidine in Patients With Treatment-Naïve Stage I-II Extranodal Natural Killer/T-Cell Lymphoma (SCENT-3)
This is an open-label, single-arm, multi-center Phase II clinical trial evaluating the efficacy and safety of a novel sequential regimen as first-line therapy for treatment-naïve patients with Extranodal NK/T-cell Lymphoma (ENKTL). The study consists of a Screening Phase, a Safety Lead-in Phase, and a Treatment Phase. During the Safety Lead-in Phase, 6 patients will be enrolled to receive a fixed dose of Sintilimab and Chidamide combined with Azacitidine to verify the dose (testing 100mg/d on days 1-3 versus days 1-5). Following the lead-in, all subjects will undergo a 2-cycle Immunotherapy Induction Phase with the SCA regimen (Sintilimab, Chidamide, and Azacitidine). Subsequently, treatment will be stratified based on response: patients achieving Complete Response (CR) or Partial Response (PR) will receive 4 additional cycles of SCA consolidation, while those with Stable Disease (SD) or Progressive Disease (PD) will switch to 4 cycles of P-GemOx chemotherapy. Upon completion of systemic therapy, all patients will undergo consolidative involved-field radiotherapy (≥50Gy).
- Conditions
- Complete Remission Rate， CRR, Progression Free Survival, Overall Survival, Adverse Event, Duration of Response
- Being tested
- SCA Induction followed by Response-Adapted Therapy
- Keywords
- Extranodal NK/T-cell Lymphoma, First-line Therapy, Sintilimab, Chidamide, Azacitidine
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCA Induction followed by Response-Adapted TherapyDrug
Drug: Sintilimab, Chidamide, and Azacitidine (SCA Regimen) Safety Lead-in: Patients receive Sintilimab (fixed dose) and Chidamide (fixed dose) combined with Azacitidine at two dose levels (100mg/d on days 1-3 vs. days 1-5) to verify the combination dose.
Induction Phase: All enrolled patients receive 2 cycles of SCA induction: Sintilimab (200mg, D1), Chidamide (30mg, biw, D1-21), and Azacitidine (100mg, D1-3/5 [SCA]). Cycle length is 21 days.
Response-Adapted Consolidation:
Patients achieving Complete Response (CR) or Partial Response (PR) continue with 4 cycles of the SCA regimen.
Patients with Stable Disease (SD) or Progressive Disease (PD) switch to 4 cycles of P-GemOx chemotherapy (Pemetrexed + Gemcitabine + Oxaliplatin).
Radiation: Involved-Field Radiotherapy (IFRT) Following the completion of immunotherapy or chemotherapy, all patients receive local radiotherapy (≥50Gy).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: SCA Induction followed by Response-Adapted Therapy | Experimental | Drug: Sintilimab, Chidamide, and Azacitidine (SCA Regimen) Safety Lead-in: Patients receive Sintilimab (fixed dose) and Chidamide (fixed dose) combined with Azacitidine at two dose levels (100mg/d on days 1-3 vs. days 1-5) to verify the combination dose.
Induction Phase: All enrolled patients receive 2 cycles of SCA induction: Sintilimab (200mg, D1), Chidamide (30mg, biw, D1-21), and Azacitidine (100mg, D1-3/5 [SCA]). Cycle length is 21 days.
Response-Adapted Consolidation:
Patients achieving Complete Response (CR) or Partial Response (PR) continue with 4 cycles of the SCA regimen.
Patients with Stable Disease (SD) or Progressive Disease (PD) switch to 4 cycles of P-GemOx chemotherapy (Pemetrexed + Gemcitabine + Oxaliplatin).
Radiation: Involved-Field Radiotherapy (IFRT) Following the completion of immunotherapy or chemotherapy, all patients receive local radiotherapy (≥50Gy). Receives: Drug: SCA Induction followed by Response-Adapted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission rate
he Complete Remission (CR) rate is defined as the proportion of participants who achieve a confirmed Complete Remission (CR) during the study treatment period. Tumor response will be assessed by the Investigator according to the Lugano Classification 2014 criteria for malignant lymphoma (or RECIL 2017 if applicable).
Complete Remission (CR): Defined as the disappearance of all evidence of disease, including resolution of all target lesions, normalization of lymph nodes (based on size criteria), and metabolic complete response (Deauville Score 1-3) on Positron Emission Tomography-Computed Tomography (PET-CT) scans, if performed.
Assessment Schedule: Efficacy assessments (including CT/MRI and PET-CT) will be performed at baseline, at the end of the Induction Phase (after 2 cycles), at the end of Consolidation/Chemotherapy Phase (after 4 additional cycles), and prior to radiotherapy. The best overall response during the systemic therapy phase will be used to calculate the CR rate.
Measured: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.
Secondary outcomes (6)
objective response rate
the objective response rate (orr) is defined as the proportion of participants who achieve either a complete remission (cr) or a partial remission (pr) as their best overall response during the systemic treatment phase. assessments will be conducted by the investigator in accordance with the lugano classification 2014 criteria for malignant lymphoma (or recil 2017 if applicable). this measure evaluates the combined efficacy of the induction and consolidation regimens (sca and/or p-gemox) in reducing tumor burden prior to the administration of local radiotherapy.
- complete remission (cr): disappearance of all target lesions, normalization of lymph nodes, and metabolic complete response (deauville score 1-3).
- partial remission (pr): ≥50% decrease in the sum of the products of the perpendicular diameters of target lesions, taking into account the appearance of new lesions or flares in fdg-avid disease.
Measured: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.
Partial Remission (PR) rate
The Partial Remission (PR) rate is defined as the proportion of participants who achieve a Partial Remission (PR) as their best overall response during the study treatment period. Tumor response will be assessed by the Investigator according to the Lugano Classification 2014 criteria (or RECIL 2017 if applicable). This endpoint measures the efficacy of the SCA induction regimen and subsequent response-adapted therapy (SCA consolidation or P-GemOx chemotherapy) in reducing the tumor burden in patients with previously untreated ENKTL. A PR is defined as a ≥50% decrease in the sum of the products of the perpendicular diameters of target lesions, taking into account the appearance of new lesions or flares in FDG-avid disease.
Measured: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.
Progression-Free Survival
The Progression-Free Survival (PFS) is defined as the time from the date of initial treatment (first dose of the SCA regimen) to the date of disease progression or death from any cause, whichever occurs first. Disease progression will be determined by the Investigator based on radiological imaging (CT/MRI) and clinical assessment according to the Lugano Classification 2014 criteria (or RECIL 2017). Patients who do not experience the event (progression or death) at the time of data cutoff will be censored at the date of their last adequate disease assessment. Patients who initiate new anti-cancer therapy without documented progression will also be censored at the start date of the new therapy.
Measured: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Duration of Response
The Duration of Response (DoR) is defined as the time from the date of first documented response (either Complete Remission or Partial Remission) to the date of disease progression or death from any cause, whichever occurs first. Disease progression will be determined by the Investigator based on radiological imaging and clinical assessment according to the Lugano Classification 2014 criteria (or RECIL 2017). Only participants who achieve a CR or PR are evaluable for this endpoint. Patients who do not experience the event (progression or death) at the time of data cutoff will be censored at the date of their last adequate disease assessment.
Measured: From date of first documented response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall Survival
The Overall Survival (OS) is defined as the time from the date of initial treatment (first dose of the SCA regimen) to the date of death from any cause. Patients who are alive at the time of the data cutoff or who are lost to follow-up will be censored at the date of their last known contact. This endpoint serves as a key measure of the long-term efficacy and clinical benefit of the sequential SCA and P-GemOx regimen combined with radiotherapy in the treatment of previously untreated ENKTL.
Measured: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Adverse Events
The incidence and severity of Adverse Events (AEs) will be monitored and recorded throughout the study. This includes all untoward medical occurrences, laboratory abnormalities (hematology and chemistry), and serious adverse events (SAEs). The severity of each AE will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. The assessment will focus on the safety and tolerability of the SCA induction regimen (Sintilimab, Chidamide, and Azacitidine), the response-adapted consolidation therapy (SCA or P-GemOx), and the subsequent involved-field radiotherapy.
Measured: From the date of informed consent and first dose of study drug up to 30 days (or 90 days for immune-related AEs) after the last dose of study treatment or completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Remission Rate， CRRStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542912
- Sponsor's protocol ID
- SCENT-3
- Acronym
- SCENT-3
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Phase II Study of Sintilimab Combined With Chidamide and Azacitidine in Patients With Treatment-Naïve Stage I-II Extranodal Natural Killer/T-Cell Lymphoma (SCENT-3)
- ClinicalTrials.gov ID
- NCT07542912
- Acronym / sponsor ID
- SCENT-3 / SCENT-3
- Conditions
- Complete Remission Rate， CRR, Progression Free Survival, Overall Survival, Adverse Event, Duration of Response
- Keywords
- Extranodal NK/T-cell Lymphoma, First-line Therapy, Sintilimab, Chidamide, Azacitidine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm, multi-center Phase II clinical trial evaluating the efficacy and safety of a novel sequential regimen as first-line therapy for treatment-naïve patients with Extranodal NK/T-cell Lymphoma (ENKTL). The study consists of a Screening Phase, a Safety Lead-in Phase, and a Treatment Phase. During the Safety Lead-in Phase, 6 patients will be enrolled to receive a fixed dose of Sintilimab and Chidamide combined with Azacitidine to verify the dose (testing 100mg/d on days 1-3 versus days 1-5). Following the lead-in, all subjects will undergo a 2-cycle Immunotherapy Induction Phase with the SCA regimen (Sintilimab, Chidamide, and Azacitidine). Subsequently, treatment will be stratified based on response: patients achieving Complete Response (CR) or Partial Response (PR) will receive 4 additional cycles of SCA consolidation, while those with Stable Disease (SD) or Progressive Disease (PD) will switch to 4 cycles of P-GemOx chemotherapy. Upon completion of systemic therapy, all patients will undergo consolidative involved-field radiotherapy (≥50Gy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: SCA Induction followed by Response-Adapted Therapy | Experimental | Drug: SCA Induction followed by Response-Adapted TherapyDrug: Sintilimab, Chidamide, and Azacitidine (SCA Regimen) Safety Lead-in: Patients receive Sintilimab (fixed dose) and Chidamide (fixed dose) combined with Azacitidine at two dose levels (100mg/d on days 1-3 vs. days 1-5) to verify the combination dose. Induction Phase: All enrolled patients receive 2 cycles of SCA induction: Sintilimab (200mg, D1), Chidamide (30mg, biw, D1-21), and Azacitidine (100mg, D1-3/5 [SCA]). Cycle length is 21 days. Response-Adapted Consolidation: Patients achieving Complete Response (CR) or Partial Response (PR) continue with 4 cycles of the SCA regimen. Patients with Stable Disease (SD) or Progressive Disease (PD) switch to 4 cycles of P-GemOx chemotherapy (Pemetrexed + Gemcitabine + Oxaliplatin). Radiation: Involved-Field Radiotherapy (IFRT) Following the completion of immunotherapy or chemotherapy, all patients receive local radiotherapy (≥50Gy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willingness to participate in the clinical study.
- Age ≥ 18 years at the time of signing the Informed Consent Form (ICF).
- Newly diagnosed ENKTL confirmed by histopathology at the study center.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- At least one evaluable or measurable lesion
Key exclusion criteria (5 listed)
- Aggressive natural killer cell leukemia.
- Presence of hemophagocytic syndrome.
- Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
- Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
- Patients with active chronic hepatitis B or active hepatitis C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCA Induction followed by Response-Adapted TherapyDrug: Sintilimab, Chidamide, and Azacitidine (SCA Regimen) Safety Lead-in: Patients receive Sintilimab (fixed dose) and Chidamide (fixed dose) combined with Azacitidine at two dose levels (100mg/d on days 1-3 vs. days 1-5) to verify the combination dose. Induction Phase: All enrolled patients receive 2 cycles of SCA induction: Sintilimab (200mg, D1), Chidamide (30mg, biw, D1-21), and Azacitidine (100mg, D1-3/5 [SCA]). Cycle length is 21 days. Response-Adapted Consolidation: Patients achieving Complete Response (CR) or Partial Response (PR) continue with 4 cycles of the SCA regimen. Patients with Stable Disease (SD) or Progressive Disease (PD) switch to 4 cycles of P-GemOx chemotherapy (Pemetrexed + Gemcitabine + Oxaliplatin). Radiation: Involved-Field Radiotherapy (IFRT) Following the completion of immunotherapy or chemotherapy, all patients receive local radiotherapy (≥50Gy). | Drug | Experimental: SCA Induction followed by Response-Adapted Therapy |
Primary outcome
Complete Remission rate
Time frame: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.
he Complete Remission (CR) rate is defined as the proportion of participants who achieve a confirmed Complete Remission (CR) during the study treatment period. Tumor response will be assessed by the Investigator according to the Lugano Classification 2014 criteria for malignant lymphoma (or RECIL 2017 if applicable). Complete Remission (CR): Defined as the disappearance of all evidence of disease, including resolution of all target lesions, normalization of lymph nodes (based on size criteria), and metabolic complete response (Deauville Score 1-3) on Positron Emission Tomography-Computed Tomography (PET-CT) scans, if performed. Assessment Schedule: Efficacy assessments (including CT/MRI and PET-CT) will be performed at baseline, at the end of the Induction Phase (after 2 cycles), at the end of Consolidation/Chemotherapy Phase (after 4 additional cycles), and prior to radiotherapy. The best overall response during the systemic therapy phase will be used to calculate the CR rate.
6 secondary outcomes
objective response rate
Time frame: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.
Partial Remission (PR) rate
Time frame: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.
Progression-Free Survival
Time frame: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Duration of Response
Time frame: From date of first documented response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall Survival
Time frame: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Adverse Events
Time frame: From the date of informed consent and first dose of study drug up to 30 days (or 90 days for immune-related AEs) after the last dose of study treatment or completion of radiotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCA Induction followed by Response-Adapted Therapy in people with Complete Remission Rate， CRR and Progression Free Survival, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huiqiang Huang, Ph.D. (020-87343009, huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission rate (time frame: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.